A Long-term Study of AK102 in Patients With Hypercholesterolemia

Phase 2

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: 450mg AK102; Drug: 300mg AK102; Drug: 150mg AK102; Drug: Statins and/or Ezetimibe

• Registration Number: NCT04173403
• Lead Sponsor: Akeso

Brief Summary

This is a phase II, open-label, non-controlled, extended study. The main objective of this study is to evaluate the long-term efficacy and safety of AK102 in combination with basic lipid-lowering therapy in patients with hypercholesterolemia. Subjects who have participated in the AK102 studies and have completed the last visit,and who, in the opinion of the investigator, are likely to benefit from continued treatment will be enrolled in this study.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-04
• Study First Submitted: 2019-11-17
• Study First Submitted QC: 2019-11-20
• Study First Posted: 2019-11-22
• Primary Completion: 2023-02-17
• Study Completion: 2023-02-17
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-01
• Last Update Posted: 2023-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 796

Inclusion Criteria

1. Signed informed consent.
2. Body weight ≥ 40 kg for both men and women.
3. Participated in the AK102-202 study, and completed the AK102-202 study last visit.

Exclusion Criteria

1. Poor compliance in AK102-202 study per investigator's judgement.
2. AE that led to permanent discontinuation of AK102 occurred during the AK102-202 study period.
3. Prior use of PCSK9 inhibitors other than AK102.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AK102	450mg AK102	450mg AK102, Q4W, subcutaneous injection; OR 300mg AK102, Q4W, subcutaneous injection;OR 150mg AK102, Q4W, subcutaneous injection;
AK102	300mg AK102	450mg AK102, Q4W, subcutaneous injection; OR 300mg AK102, Q4W, subcutaneous injection;OR 150mg AK102, Q4W, subcutaneous injection;
AK102	150mg AK102	450mg AK102, Q4W, subcutaneous injection; OR 300mg AK102, Q4W, subcutaneous injection;OR 150mg AK102, Q4W, subcutaneous injection;
AK102	Statins and/or Ezetimibe	450mg AK102, Q4W, subcutaneous injection; OR 300mg AK102, Q4W, subcutaneous injection;OR 150mg AK102, Q4W, subcutaneous injection;

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 52	Week 52

Secondary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events as assessed by CTCAE V5.0	From baseline through 52 weeks
Percent Change From Baseline in non High-density lipoprotein (non-HDL) cholesterol	From baseline through 52 weeks
Percent Change From Baseline in Apolipoprotein A-I (Apo A-I)	From baseline through 52 weeks
Percent Change From BaPercent Change From Baseline in Total Cholesterol(TC)	From baseline through 52 weeks
Concentrations of AK102 in Serum	From baseline through 52 weeks
Number of subjects who develop detectable anti-drug antibodies (ADAs)	From baseline through 52 weeks	The immunogenicity of AK102 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies.
Percent Change From Baseline in Apolipoprotein B (Apo B)	From baseline through 52 weeks
Percent Change From Baseline in High-density lipoprotein (HDL) cholesterol	From baseline through 52 weeks
Percent Change From Baseline in Serum Triglyceride (TG) cholesterol	From baseline through 52 weeks
Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)	From baseline through 52 weeks

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China